The Safety and Effectiveness of Clarithromycin Plus Ethambutol Used With or Without Clofazimine in the Treatment of MAC in Patients With AIDS

HIV Infections Clinical Trial

Official title:

A Randomized Open-Label Study of the Tolerability and Efficacy of Clarithromycin and Ethambutol in Combination With or Without Clofazimine for the Treatment of Disseminated MAC (dMAC) in Patients With AIDS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002331
• Other study ID #: 214A
• Secondary ID: M93-069
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: January 15, 2015
• Start date: January 1994
• Est. completion date: March 1995

Study information

• Verified date: February 2009
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

PRIMARY: To assess the tolerability of the combination regimen of clarithromycin plus ethambutol with or without clofazimine in patients with disseminated Mycobacterium avium Complex (dMAC).

SECONDARY: To determine the proportion of patients achieving a sterile blood culture along with the time required to achieve it. To determine the duration of bacteriological response, defined as length of time that blood cultures remain sterile.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: March 1995
• Est. primary completion date: March 1995
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

Inclusion Criteria

Patients must have:

• History of HIV seropositivity.

• Disseminated MAC.

• Positive blood culture for MAC within 4 weeks prior to study entry.

• Consent of parent or guardian if less than 18 years of age.

• Ability to complete the study.

NOTE:

• Patients with active opportunistic infections other than dMAC are permitted if dosage and clinical parameters have been stable for 4 weeks prior to enrollment.

Exclusion Criteria

Concurrent Medication:

Excluded:

• Active therapy with carbamazepine or theophylline, unless investigator agrees to carefully monitor blood levels.

• Active therapy with investigational drugs other than treatment for HIV disease, except with approval of the sponsor.

• Concomitant terfenadine (Seldane or Seldane-D) or astemizole (Hismanal).

• Amikacin.

• Azithromycin.

• Capreomycin.

• Ciprofloxacin.

• Cycloserine.

• Ethionamide.

• Gentamicin.

• Kanamycin.

• Levofloxacin.

• Lomefloxacin.

• Ofloxacin.

• Rifampin.

• Rifabutin.

• Sparfloxacin.

• Streptomycin.

• Any other aminoglycosides, quinolones, and macrolides.

Patients with the following prior conditions are excluded:

History of allergy or hypersensitivity to macrolides, ethambutol, or clofazimine.

Prior Medication:

Excluded:

• Other antimycobacterials, including aminoglycosides, ansamycin (rifabutin), other macrolides (such as clindamycin), quinolones, and rifampin, between screening and study entry.

• Clarithromycin or azithromycin as prophylaxis or treatment (for any cause) for more than 14 days cumulative within the past 2 months.

Study Design

Endpoint Classification: Efficacy Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• HIV Infections
• Infection
• Mycobacterium Avium-intracellular Infection
• Mycobacterium avium-intracellulare Infection
• Mycobacterium Infections

Intervention

Drug:
• Ethambutol hydrochloride

• Clarithromycin

• Clofazimine

Locations

Country	Name	City	State
Puerto Rico	Dr Javier Morales	Condado San Juan
United States	Johns Hopkins Univ School of Medicine	Baltimore	Maryland
United States	Univ of North Carolina School of Medicine	Chapel Hill	North Carolina
United States	Rush Presbyterian - Saint Luke's Med Ctr	Chicago	Illinois
United States	Univ of Texas Southwestern Med Ctr of Dallas	Dallas	Texas
United States	Houston Veterans Administration Med Ctr	Houston	Texas
United States	Kaiser Permanente Med Ctr	Los Angeles	California
United States	Dr Margaret Fischel	Miami	Florida
United States	Vanderbilt Univ School of Medicine	Nashville	Tennessee
United States	Tulane Univ Med School	New Orleans	Louisiana
United States	Beth Israel Med Ctr	New York	New York
United States	Mount Sinai Med Ctr	New York	New York
United States	Dr Stephen Hauptman	Philadelphia	Pennsylvania
United States	UCD Med Ctr	Sacramento	California
United States	Kaiser Permanente Med Ctr	San Francisco	California
United States	Santa Clara Valley Med Ctr	San Jose	California
United States	Saint Joseph's Hosp / Infectious Disease Rsch Institute	Tampa	Florida
United States	George Washington Univ Med Ctr	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Countries where clinical trial is conducted

United States,  Puerto Rico, 

References & Publications (1)

Chaisson RE, Keiser P, Pierce M, Fessel WJ, Ruskin J, Lahart C, Benson CA, Meek K, Siepman N, Craft JC. Clarithromycin and ethambutol with or without clofazimine for the treatment of bacteremic Mycobacterium avium complex disease in patients with HIV infection. AIDS. 1997 Mar;11(3):311-7. — View Citation